Compatibility mechanisms for devices in a continuous analyte monitoring system and methods thereof

ABSTRACT

Methods, devices, and kits are provided for determining a compatibility of one or more devices in an analyte monitoring system.

RELATED APPLICATIONS

The present application is a continuation of U.S. patent applicationSer. No. 15/640,058, filed Jun. 30, 2017, which is a continuation ofU.S. patent application Ser. No. 15/065,604, filed Mar. 9, 2016, nowU.S. Pat. No. 9,721,063, which is a continuation of U.S. patentapplication Ser. No. 13/684,085, filed Nov. 21, 2012, now U.S. Pat. No.9,317,656, which claims the benefit of U.S. Provisional PatentApplication No. 61/563,517, filed Nov. 23, 2011, all of which areincorporated herein by reference in their entireties for all purposes.

BACKGROUND

The detection of the level of glucose or other analytes, such aslactate, oxygen or the like, in certain individuals is vitally importantto their health. For example, the monitoring of glucose is particularlyimportant to individuals with diabetes. Diabetics may need to monitorglucose levels to determine when insulin is needed to reduce glucoselevels in their bodies or when additional glucose is needed to raise thelevel of glucose in their bodies.

Devices have been developed for continuous or automatic monitoring ofanalytes, such as glucose, in bodily fluid such as in the blood streamor in interstitial fluid. Some of these analyte measuring devices areconfigured so that at least a portion of the devices are positionedbelow a skin surface of a user, e.g., in a blood vessel or in thesubcutaneous tissue of a user.

SUMMARY

Embodiments of the present disclosure include computer-implementedmethods for determining a compatibility of one or more devices in ananalyte monitoring system. Certain aspects include receivingidentification code data related to a configuration of a first device,retrieving information including a predetermined list of one or moreacceptable identification code data that is related to one or more firstdevice configurations that are compatible with the analyte monitoringsystem, comparing the received identification code data with the one ormore acceptable identification codes from the retrieved predeterminedlist and determining if the configuration of the first device iscompatible with the analyte monitoring system based upon the receivedidentification code data being identified in the predetermined list ofacceptable identification code data.

Embodiments of the present disclosure include computer-implementedmethods for determining a compatibility of one or more devices in ananalyte monitoring system. Certain aspects include receivingidentification code data related to a configuration of a first device,retrieving information including a predetermined list of one or moreidentification codes that are related to one or more first deviceconfigurations and one or more software functions relating to the one ormore first device configurations, comparing the received identificationcode data with the one or more identification codes and determining anappropriate software function for processing analyte data obtained bythe first device that is related to an analyte level of a user basedupon a stored software function that corresponds to the receivedidentification code data.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a block diagram of a data monitoring and managementsystem for practicing one or more embodiments of the present disclosure;

FIG. 2 illustrates a data monitoring and management system for real timeglucose measurement data acquisition and processing in one aspect of thepresent disclosure;

FIG. 3 is a block diagram of a receiver/monitor unit such as that shownin FIG. 1 in accordance with certain embodiments;

FIG. 4 is a flowchart illustrating a method for determining acompatibility of one or more devices in an analyte monitoring system inaccordance with certain embodiments of the present disclosure;

FIG. 5 is a flowchart illustrating a method for determining acompatibility of one or more devices in an analyte monitoring system inaccordance with certain embodiments of the present disclosure; and

FIG. 6 is a flowchart illustrating a method for determining acompatibility of one or more devices in an analyte monitoring system inaccordance with certain embodiments of the present disclosure.

DETAILED DESCRIPTION

Before the present disclosure is further described, it is to beunderstood that this disclosure is not limited to particular embodimentsdescribed, as such may, of course, vary. It is also to be understoodthat the terminology used herein is for the purpose of describingparticular embodiments only, and is not intended to be limiting, sincethe scope of the present disclosure will be limited only by the appendedclaims.

As will be apparent to those of skill in the art upon reading thisdisclosure, each of the individual embodiments described and illustratedherein has discrete components and features which may be readilyseparated from or combined with the features of any of the other severalembodiments without departing from the scope or spirit of the presentdisclosure.

Where a range of values is provided, it is understood that eachintervening value, to the tenth of the unit of the lower limit unlessthe context clearly dictates otherwise, between the upper and lowerlimit of that range and any other stated or intervening value in thatstated range, is encompassed within the disclosure. The upper and lowerlimits of these smaller ranges may independently be included in thesmaller ranges, and are also encompassed within the disclosure, subjectto any specifically excluded limit in the stated range. Where the statedrange includes one or both of the limits, ranges excluding either orboth of those included limits are also included in the disclosure.

Unless defined otherwise, all technical and scientific terms used hereinhave the same meaning as commonly understood by one of ordinary skill inthe art to which this disclosure belongs. Although many methods andmaterials similar or equivalent to those described herein can also beused in the practice or testing of the present disclosure, exemplarymethods and materials are now described. All publications mentionedherein are incorporated herein by reference to disclose and describe themethods and/or materials in connection with which the publications arecited.

As used herein and in the appended claims, the singular forms “a,” “an,”and “the” include plural referents unless the context clearly dictatesotherwise. It is further noted that the claims may be drafted to excludeany optional element. As such, this statement is intended to serve asantecedent basis for use of such exclusive terminology as “solely,”“only” and the like in connection with the recitation of claim elements,or use of a “negative” limitation.

The publications discussed herein are provided solely for theirdisclosure prior to the filing date of the present application. Nothingherein is to be construed as an admission that the present disclosure isnot entitled to antedate such publication by virtue of prior disclosure.Further, the dates of publication provided may be different from theactual publication dates which may need to be independently confirmed.

FIG. 1 shows a data monitoring and management system such as, forexample, an analyte (e.g., glucose) monitoring system in accordance withcertain embodiments of the present disclosure. Embodiments of thesubject disclosure are described primarily with respect to glucosemonitoring devices and systems, and methods of using two or more devicesin a glucose monitoring system to determine the compatibility of one ormore devices in the glucose monitoring system.

Analytes that may be monitored include, but are not limited to, acetylcholine, amylase, bilirubin, cholesterol, chorionic gonadotropin,creatine kinase (e.g., CK-MB), creatine, DNA, fructosamine, glucose,glutamine, growth hormones, hormones, ketones, lactate, peroxide,prostate-specific antigen, prothrombin, RNA, thyroid stimulatinghormone, and troponin. The concentration of drugs, such as, for example,antibiotics (e.g., gentamicin, vancomycin, and the like), digitoxin,digoxin, drugs of abuse, theophylline, and warfarin, may also bemonitored. In those embodiments that monitor more than one analyte, theanalytes may be monitored at the same or different times.

Referring to FIG. 1, the analyte monitoring system 100 includes a sensor101, a data processing unit (e.g., sensor electronics) 102 connectableto the sensor 101, and a primary receiver unit 104 which is configuredto communicate with the data processing unit 102 via a communicationlink 103. In aspects of the present disclosure, the sensor 101 and thedata processing unit (sensor electronics) 102 may be configured as asingle integrated assembly 110. In certain embodiments, the integratedsensor and sensor electronics assembly 110 may be configured as anon-body patch device. In such embodiments, the on-body patch device maybe configured for, for example, RFID or RF communication with a readerdevice/receiver unit, and/or an insulin pump.

In certain embodiments, the primary receiver unit 104 may be furtherconfigured to transmit data to a data processing terminal 105 toevaluate or otherwise process or format data received by the primaryreceiver unit 104. The data processing terminal 105 may be configured toreceive data directly from the data processing unit 102 via acommunication link which may optionally be configured for bi-directionalcommunication. Further, the data processing unit 102 may include atransmitter or a transceiver to transmit and/or receive data to and/orfrom the primary receiver unit 104, the data processing terminal 105 oroptionally the secondary receiver unit 106.

Also shown in FIG. 1 is an optional secondary receiver unit 106 which isoperatively coupled to the communication link and configured to receivedata transmitted from the data processing unit 102. The secondaryreceiver unit 106 may be configured to communicate with the primaryreceiver unit 104, as well as the data processing terminal 105. Thesecondary receiver unit 106 may be configured for bi-directionalwireless communication with each of the primary receiver unit 104 andthe data processing terminal 105. As discussed in further detail below,in certain embodiments the secondary receiver unit 106 may be ade-featured receiver as compared to the primary receiver unit 104, i.e.,the secondary receiver unit 106 may include a limited or minimal numberof functions and features as compared with the primary receiver unit104. As such, the secondary receiver unit 106 may include a smaller (inone or more, including all, dimensions), compact housing or embodied ina device such as a wrist watch, arm band, etc., for example.Alternatively, the secondary receiver unit 106 may be configured withthe same or substantially similar functions and features as the primaryreceiver unit 104. The secondary receiver unit 106 may include a dockingportion to be mated with a docking cradle unit for placement by, e.g.,the bedside for night time monitoring, and/or bi-directionalcommunication device.

Only one sensor 101, data processing unit 102 and data processingterminal 105 are shown in the embodiment of the analyte monitoringsystem 100 illustrated in FIG. 1. However, it will be appreciated by oneof ordinary skill in the art that the analyte monitoring system 100 mayinclude more than one sensor 101 and/or more than one data processingunit 102, and/or more than one data processing terminal 105.

The analyte monitoring system 100 may be a continuous monitoring system,or semi-continuous, or a discrete monitoring system. In amulti-component environment, each component may be configured to beuniquely identified by one or more of the other components in the systemso that communication conflict may be readily resolved between thevarious components within the analyte monitoring system 100. Forexample, unique IDs, communication channels, and the like, may be used.

In certain embodiments, the sensor 101 is physically positioned in or onthe body of a user whose analyte level is being monitored. The sensor101 may be configured to at least process and send data related to itsconfiguration into a corresponding signal for transmission by the dataprocessing unit 102.

The data processing unit 102 is coupleable to the sensor 101 so thatboth devices are positioned in or on the user's body, with at least aportion of the analyte sensor 101 positioned transcutaneously. The dataprocessing unit 102 in certain embodiments may include a portion of thesensor 101 (proximal section of the sensor in electrical communicationwith the data processing unit 102) which is encapsulated within or onthe printed circuit board of the data processing unit 102 with, forexample, potting material or other protective material. The dataprocessing unit 102 performs data processing functions, where suchfunctions may include but are not limited to, filtering and encoding ofdata signals, each of which corresponds to a sampled analyte level ofthe user, for transmission to the primary receiver unit 104 via thecommunication link 103. In one embodiment, the sensor 101 or the dataprocessing unit 102 or a combined sensor/data processing unit may bewholly implantable under the skin layer of the user.

In one aspect, the primary receiver unit 104 may include an analoginterface section including an RF receiver and an antenna that isconfigured to communicate with the data processing unit 102 via thecommunication link 103, and a data processing section for processing thereceived data from the data processing unit 102 such as data decoding,error detection and correction, data clock generation, and/or data bitrecovery.

In operation, the primary receiver unit 104 in certain embodiments isconfigured to synchronize with the data processing unit 102 to uniquelyidentify the data processing unit 102, based on, for example,identification information of the data processing unit 102, andthereafter, to periodically receive signals transmitted from the dataprocessing unit 102 associated with the monitored analyte levelsdetected by the sensor 101. That is, when operating in the CGM mode, thereceiver unit 104 in certain embodiments is configured to automaticallyreceive data related to the configuration of the sensor from the analytesensor/sensor electronics when the communication link (e.g., RF range)is maintained or opened between these components.

Referring again to FIG. 1, the data processing terminal 105 may includea personal computer, portable data processing devices or computers suchas a laptop computer or a handheld device (e.g., personal digitalassistants (PDAs), communication devices such as a cellular phone (e.g.,a multimedia and Internet-enabled mobile phone such as an iPhone, aBlackberry device, a Palm device such as Palm Pre, Treo, or similarphone), mp3 player, pager, and the like), drug delivery device, insulinpump, each of which may be configured for data communication with thereceiver via a wired or a wireless connection. Additionally, the dataprocessing terminal 105 may further be connected to a data network (notshown).

The data processing terminal 105 may include an infusion device such asan insulin infusion pump or the like, which may be configured toadminister insulin to patients, and which may be configured tocommunicate with the primary receiver unit 104 for receiving, amongothers, the measured analyte level or configuration data. Alternatively,the primary receiver unit 104 may be configured to integrate an infusiondevice therein so that the primary receiver unit 104 is configured toadminister insulin (or other appropriate drug) therapy to patients, forexample, for administering and modifying basal profiles, as well as fordetermining appropriate boluses for administration based on, amongothers, the detected analyte levels received from the data processingunit 102. An infusion device may be an external device or an internaldevice (wholly implantable in a user).

In particular embodiments, the data processing terminal 105, which mayinclude an insulin pump, may be configured to receive the configurationsignals from the data processing unit 102, and thus, incorporate thefunctions of the primary receiver unit 104 including data processing formanaging the patient's insulin therapy and analyte monitoring. Incertain embodiments, the communication link 103 as well as one or moreof the other communication interfaces shown in FIG. 1 may use one ormore of an RF communication protocol, an infrared communicationprotocol, a Bluetooth enabled communication protocol, an 802.11xwireless communication protocol, or an equivalent wireless communicationprotocol which would allow secure, wireless communication of severalunits (for example, per HIPPA requirements) while avoiding potentialdata collision and interference.

As described in aspects of the present disclosure, the analytemonitoring system may include an on-body patch device with a thinprofile that can be worn on the arm or other locations on the body (andunder clothing worn by the user or the patient), the on-body patchdevice including an analyte sensor and circuitry and components foroperating the sensor and processing and storing signals, includingconfiguration signals, received from the sensor as well as forcommunication with the reader device. For example, one aspect of theon-body patch device may include electronics to sample the voltagesignal received from the analyte sensor in fluid contact with the bodyfluid, and to process the sampled voltage signals into the correspondingglucose values and/or store the sampled voltage signal as raw data, orto send configuration information as a signal or data.

In certain embodiments, the on-body patch device includes an antennasuch as a loop antenna to receive RF power from an external device suchas the reader device/receiver unit described above, electronics toconvert the RF power received via the antenna into DC (direct current)power for the on-body patch device circuitry, communication module orelectronics to detect commands received from the reader device, andcommunication component to transmit data to the reader device, a lowcapacity battery for providing power to sensor sampling circuitry (forexample, the analog front end circuitry of the on-body patch device insignal communication with the analyte sensor), one or more non-volatilememory or storage devices to store data including raw signals from thesensor or processed data based on the raw sensor signals. Morespecifically, in the on operation demand mode, the on-body patch devicein certain embodiments is configured to transmit real time analyterelated data and/or stored historical analyte related data, and/orconfiguration data when within the RF power range of the reader device.The configuration data can be transmitted prior to transmitting the realtime analyte related data.

In certain embodiments, a data processing module/terminal may beprovided in the analyte monitoring system that is configured to operateas a data logger, interacting or communicating with the on-body patchdevice by, for example, transmitting requests for configurationinformation to the on-body patch device, and storing the responsiveconfiguration information received from the on-body patch device in oneor more memory components of the data processing module (e.g., repeaterunit). Further, data processing module may be configured as a compacton-body relay device to relay or retransmit the received analyte levelinformation from the on-body patch device to the reader device/receiverunit or the remote terminal or both. The data processing module in oneaspect may be physically coupled to the on-body patch device, forexample, on a single adhesive patch on the skin surface of the patient.Alternatively, the data processing module may be positioned close to butnot in contact with the on-body patch device. For example, when theon-body patch device is positioned on the abdomen of the patient, thedata processing module may be worn on a belt of the patient or the user,such that the desired close proximity or predetermined distance ofapproximately 1-5 inches (or about 1-10 inches, for example, or more)between the on-body patch device and the data processing module may bemaintained.

The various processes described above including the processes operatingin the software application execution environment in the analytemonitoring system including the on-body patch device, the reader device,data processing module and/or the remote terminal performing one or moreroutines described above may be embodied as computer programs developedusing an object oriented language that allows the modeling of complexsystems with modular objects to create abstractions that arerepresentative of real world, physical objects and theirinterrelationships. The software required to carry out the inventiveprocess, which may be stored in a memory or storage device of thestorage unit of the various components of the analyte monitoring systemdescribed above in conjunction to the Figures including the on-bodypatch device, the reader device, the data processing module, variousdescribed communication devices, or the remote terminal may be developedby a person of ordinary skill in the art and may include one or morecomputer program products.

In one embodiment, an apparatus for bi-directional communication with ananalyte monitoring system may comprise a storage device having storedtherein one or more routines, a processing unit operatively coupled tothe storage device and configured to retrieve the stored one or moreroutines for execution, a data transmission component operativelycoupled to the processing unit and configured to transmit data based atleast in part on the one or more routines executed by the processingunit, and a data reception component operatively coupled to theprocessing unit and configured to receive configuration data from aremote location and to store the received configuration data in thestorage device for retransmission, wherein the data transmissioncomponent is programmed to transmit a query to a remote location, andfurther wherein the data reception component receives the configurationdata from the remote location in response to the transmitted query whenone or more electronics in the remote location transitions from aninactive state to an active state upon detection of the query from thedata transmission component.

FIG. 2 illustrates a data monitoring and management system for deviceconfiguration related data acquisition and processing in one aspect ofthe present disclosure. More specifically, as shown in FIG. 2, theon-body patch device 211 including sensor electronics coupled to ananalyte sensor 250 is positioned on a skin surface 210 of a patient or auser.

Referring back to FIG. 2, as shown, when the reader device/receiver unit220 is positioned or placed in close proximity and within apredetermined range of the on-body patch device 211, the RF power supplyin the reader device/receiver unit 220 may be configured to provide thenecessary power to operate the electronics in the on-body patch device211, and the on-body patch device 211 may be configured to, upondetection of the RF power from the reader device/receiver unit 220,perform preprogrammed routines including, for example, transmitting oneor more signals 240 to the reader device/receiver unit 220 indicative ofthe configuration of the analyte sensor 250.

In certain embodiments, the reader device/receiver unit 220 may includean RF power switch that is user activatable or activated uponpositioning within a predetermined distance from the on-body patchdevice 211 to turn on the analyte sensor in the on-body patch device211. That is, using the RF signal, the analyte sensor coupled to thesensor electronics in the on-body patch device 211 may be initialized oractivated. In another embodiment, a passive RFID function may beprovided or programmed such that upon receiving a “turn on” signalwhich, when authenticated, will turn on the electronic power switch thatactivates the on-body patch device 211. That is, the passive RFIDconfiguration may include drawing energy from the RF field radiated fromthe reader device/receiver unit 220 so as to prompt for and/or detectthe “turn on” signal which, upon authentication, activates the on-bodypatch device 211.

In one embodiment, communication and/or RF power transfer between thereader device/receiver unit 220 and the on-body patch device 211 may beautomatically initiated when the reader device/receiver unit 220 isplaced in close proximity to the on-body patch device 211 as discussedabove. Alternatively, the reader device/receiver unit 220 may beconfigured such that user activation, such as data request initiationand subsequent confirmation by the user using, for example, the display222 and/or input components 221 of the reader device/receiver unit 220,may be required prior to the initiation of communication and/or RF powertransfer between the reader device/receiver unit 220 and the on-bodypatch device 211. In a further embodiment, the reader device/receiverunit 220 may be user configurable between multiple modes, such that theuser may choose whether the communication between the readerdevice/receiver unit 220 and on-body patch device 211 is performedautomatically or requires a user activation and/or confirmation.

As further shown in FIG. 2, the display 222 of the readerdevice/receiver unit 220 may be configured to provide thefunctionalities of a user interface to present information such as alarmor alert notification to the user. In one aspect, the readerdevice/receiver unit 220 may include other output components such as aspeaker, vibratory output component and the like to provide audibleand/or vibratory output indication to the user in addition to the visualoutput indication provided on the display 222.

As discussed, some or all of the electronics in the on-body patch device211 in one embodiment may be configured to rely on the RF power receivedfrom the reader device/receiver unit 220 to perform transmission of theconfiguration information to the reader device/receiver unit 220. Thatis, the on-body patch device 211 may be discreetly worn on the body ofthe user or the patient, and under clothing, for example, and whendesired, by positioning the reader device/receiver unit 220 within apredetermined distance from the on-body patch device 211, configurationinformation may be received by the reader device/receiver unit 220.

Referring still to FIG. 2, also shown are a data processingmodule/terminal 260 and a remote terminal 270. In one aspect, dataprocessing module 260 may include a stand alone device configured forbi-directional communication to communicate with the on-body patchdevice 211, the reader device/receiver unit 220 and/or the remoteterminal 270. More specifically, data processing module 260 may includeone or more microprocessors or similar data processing componentsconfigured to execute one or more software routines for communication,as well as data storage and retrieval to and from one or more memorycomponents provided in the housing of the data processing module 260.

The data processing module 260 in one embodiment may be configured tocommunicate with the on-body patch device 211 in a similar manner as thereader device/receiver unit 220 and may include communication componentssuch as antenna, power supply and memory, among others, for example, toallow provision of RF power to the on-body patch device 211 or torequest or prompt the on-body patch device 211 to send the configurationdata and optionally stored analyte related data. The data processingmodule 260 may be configured to interact with the on-body patch device211 in a similar manner as the reader device/receiver unit 220 such thatthe data processing module 260 may be positioned within a predetermineddistance from the on-body patch device 211 for communication with theon-body patch device 211.

In one aspect, the on-body patch device 211 and the data processingmodule 260 may be positioned on the skin surface of the user or thepatient within the predetermined distance of each other (for example,within approximately 5 inches or less) such that the communicationbetween the on-body patch device 211 and the data processing module 260is maintained. In a further aspect, the housing of the data processingmodule 260 may be configured to couple to or cooperate with the housingof the on-body patch device 211 such that the two devices are combinedor integrated as a single assembly and positioned on the skin surface.

Referring again to FIG. 2, the data processing module 260 may beconfigured or programmed to prompt or ping the on-body patch device 211at a predetermined time interval such as upon activation of the on-bodypatch device 211, or once every five minutes or once every 30 minutes orany other suitable or desired programmable time interval to requestconfiguration data from the on-body patch device 211 which is receivedand is stored in one or more memory devices or components of the dataprocessing module 260. In another embodiment, the data processing module260 is configured to prompt or ping the on-body patch device 211 whendesired by the patient or the user on-demand, and not based on apredetermined time interval.

As further shown in FIG. 2, the data processing module 260 in one aspectmay be configured to transmit the stored data received from the on-bodypatch device 211 to the reader device/receiver unit 220 whencommunication between the data processing module 260 and the readerdevice/receiver unit 220 is established. More specifically, in additionto RF antenna and RF communication components described above, dataprocessing module 260 may include components to communicate using one ormore wireless communication protocols such as, for example, but notlimited to, infrared (IR) protocol, Bluetooth protocol, Zigbee protocol,and 802.11 wireless LAN protocol. Additional description ofcommunication protocols including those based on Bluetooth protocoland/or Zigbee protocol can be found in U.S. Patent Publication No.2006/0193375 incorporated herein by reference for all purposes. The dataprocessing module 260 may further include communication ports, driversor connectors to establish wired communication with one or more of thereader device/receiver unit 220, on-body patch device 211, or the remoteterminal 270 including, for example, but not limited to USB connectorand/or USB port, Ethernet connector and/or port, FireWire connectorand/or port, or RS-232 port and/or connector.

In one aspect, the data processing module 260 may be configured tooperate as a data logger configured or programmed to periodicallyrequest or prompt the on-body patch device 211 to transmit theconfiguration information, and to store the received information forlater retrieval or subsequent transmission to the reader device/receiverunit 220 or to the remote terminal 270 or both, for further processingand analysis.

In a further aspect, the functionalities of the data processing module260 may be configured or incorporated into a memory device such as an SDcard, microSD card, compact flash card, XD card, Memory Stick card,Memory Stick Duo card, or USB memory stick/device including softwareprogramming resident in such devices to execute upon connection to therespective one or more of the on-body patch device 211, the remoteterminal 270 or the reader device/receiver unit 220. In a furtheraspect, the functionalities of the data processing module 260, includingexecutable software and programming, may be provided to a communicationdevice such as a mobile telephone including, for example, iPhone, iPodTouch, Blackberry device, Palm based device (such as Palm Pre, Treo,Treo Pro, Centro), personal digital assistants (PDAs) or any othercommunication enabled operating system (such as Windows or Androidoperating systems) based mobile telephones as a downloadable applicationfor execution by the downloading communication device. To this end, theremote terminal 270 as shown in FIG. 2 may include a personal computer,or a server terminal that is configured to provide the executableapplication software to the one or more of the communication devicesdescribed above when communication between the remote terminal 270 andthe devices are established.

Depending upon the user setting or configuration on the communicationdevice, the downloaded application may be programmed or customized usingthe user interface of the respective communication device (screen,keypad, and the like) to establish or program the desired settings suchas a receiver alarm, an insulin pump alarm, sensor replacement alarm, orany other alarm or alert conditions as may be desired by the user.Moreover, the programmed notification settings on the communicationdevice may be output using the output components of the respectivecommunication devices, such as speaker, vibratory output component, orvisual output/display. As a further example, the communication devicemay be provided with programming and application software to communicatewith the on-body patch device 211 such that a frequency or periodicityof data acquisition is established. In this manner, the communicationdevice may be configured to conveniently receive configurationinformation from the on-body patch device 211 at predetermined timeperiods such as, for example, but not limited to during an activation ofthe on-body patch device 211, once every minute, once every fiveminutes, or once every 10 or 15 minutes, and store the receivedinformation, as well as to provide a desired or appropriate warningindication or notification to the user or the patient.

FIG. 3 is a block diagram of a receiver/monitor unit or insulin pumpsuch as that shown in FIG. 1 in accordance with certain embodiments. Theprimary receiver unit 104 (FIG. 1) includes one or more of: a bloodglucose test strip interface 301, an RF receiver 302, an input 303, atemperature detection section 304, and a clock 305, each of which isoperatively coupled to a processing and storage section 307. The primaryreceiver unit 104 also includes a power supply 306 operatively coupledto a power conversion and monitoring section 308. Further, the powerconversion and monitoring section 308 is also coupled to the receiverprocessor 307. Moreover, also shown are a receiver serial communicationsection 309, and an output 310, each operatively coupled to theprocessing and storage unit 307. The receiver may include user inputand/or interface components or may be free of user input and/orinterface components.

In one aspect, the RF receiver 302 is configured to communicate, via thecommunication link 103 (FIG. 1) with the data processing unit (sensorelectronics) 102, to receive encoded data from the data processing unit102 for, among others, signal mixing, demodulation, and other dataprocessing. The input 303 of the primary receiver unit 104 is configuredto allow the user to enter information into the primary receiver unit104 as needed. In one aspect, the input 303 may include keys of akeypad, a touch-sensitive screen, and/or a voice-activated input commandunit, and the like. The temperature monitor section 304 may beconfigured to provide temperature information of the primary receiverunit 104 to the processing and control section 307, while the clock 305provides, among others, real time or clock information to the processingand storage section 307.

Each of the various components of the primary receiver unit 104 shown inFIG. 3 is powered by the power supply 306 (or other power supply) which,in certain embodiments, includes a battery. Furthermore, the powerconversion and monitoring section 308 is configured to monitor the powerusage by the various components in the primary receiver unit 104 foreffective power management and may alert the user, for example, in theevent of power usage which renders the primary receiver unit 104 insub-optimal operating conditions. The serial communication section 309in the primary receiver unit 104 is configured to provide abi-directional communication path from the testing and/or manufacturingequipment for, among others, initialization, testing, and configurationdetermination of the primary receiver unit 104.

Serial communication section 104 can also be used to upload data to acomputer, such as configuration data. The communication link with anexternal device (not shown) can be made, for example, by cable (such asUSB or serial cable), infrared (IR) or RF link. The output/display 310of the primary receiver unit 104 is configured to provide, among others,a graphical user interface (GUI), and may include a liquid crystaldisplay (LCD) for displaying information. Additionally, theoutput/display 310 may also include an integrated speaker for outputtingaudible signals as well as to provide vibration output as commonly foundin handheld electronic devices, such as mobile telephones, pagers, etc.In certain embodiments, the primary receiver unit 104 also includes anelectro-luminescent lamp configured to provide backlighting to theoutput 310 for output visual display in dark ambient surroundings.

Referring back to FIG. 3, the primary receiver unit 104 may also includea storage section such as a programmable, non-volatile memory device aspart of the processor 307, or provided separately in the primaryreceiver unit 104, operatively coupled to the processor 307. Theprocessor 307 may be configured to perform Manchester decoding (or otherprotocol(s)) as well as error detection and correction upon the encodeddata received from the data processing unit 102 via the communicationlink 103.

In further embodiments, the data processing unit 102 and/or the primaryreceiver unit 104 and/or the secondary receiver unit 106, and/or thedata processing terminal/infusion section 105 of FIG. 1 may beconfigured to receive the blood glucose value wirelessly over acommunication link from, for example, a blood glucose meter. In furtherembodiments, a user manipulating or using the analyte monitoring system100 (FIG. 1) may manually input the blood glucose value using, forexample, a user interface (for example, a keyboard, keypad, voicecommands, and the like) incorporated in the one or more of the dataprocessing unit 102, the primary receiver unit 104, secondary receiverunit 106, or the data processing terminal/infusion section 105.

Additional detailed descriptions are provided in U.S. Pat. Nos.5,262,035; 5,264,104; 5,262,305; 5,320,715; 5,593,852; 6,175,752;6,650,471; 6,746, 582, 6,284,478, 7,299,082, and 7,811,231, inapplication Ser. No. 11/060,365, filed Feb. 16, 2005 titled “Method andSystem for Providing Data Communication in Continuous Glucose MonitoringAnd Management System”, in application Ser. No. 12/698,124, filed Feb.1, 2010, titled “Compact On-Body Physiological Monitoring Devices andMethods Thereof”, and in application Ser. No. 12/807,278, filed Aug. 31,2010 titled “Medical Devices and Methods”, each of which is incorporatedherein by reference.

Sensors for continuous glucose monitoring systems can be continuallyimproved and these updated versions of the sensors will be madeavailable to consumers. An important consideration for updated sensorproducts is to ensure that on market system components (e.g., receiverdevices, repeater units, glucose meters, insulin pumps, etc.) will workwith specific components of the sensor that has been updated. Anotherconsideration is to exclude updated components from operation withcertain components if such operation is not safe and effective. Forinstance, some CGM algorithms may be designed to work with a particulartype of sensor but not with others.

In certain embodiments, electronic system update configurationrequirements can be enforced using key codes that are incorporated inthe communication messages sent between system components. Sensorconfiguration updates can be managed using a key code technique. Sincesensors themselves may not be capable of interacting with othercomponents using key codes, such features may be integrated along withthe sensor or sensor delivery system. For instance, in some embodiments,the sensor may provide a radio ID or a resistive code to indicate itsconfiguration to the other system components. The sensor electronics(e.g., transmitter) may use these means to detect the sensor version inorder to further manage component configuration (e.g., communicating thesensor version information to other components using key codes). Thesensor electronics may have a range of sensor codes that it can accept,or the sensor electronics may pass the sensor code data to the receiverdevice (or other device in the system) that can have a range of sensorcodes that it accepts. Similarly, the transmitter can have a range ofacceptable receiver codes and a receiver can have a range of acceptabletransmitter codes. In certain embodiments, if the receiver devicedetects a sensor version that is not allowable or if the transmittersends the receiver a message indicating that the attached sensor was notallowable, it can notify the user that the sensor version is notallowable. Moreover, the transmitter and/or receiver software can changealgorithms or other software functions dependent on the detectedsoftware version.

In certain embodiments, key codes can be incorporated in communicationmessages sent through the devices in the analyte monitoring system. Keycodes are primarily available for access by electronic devices. Thecodes may be used as a book keeping tool to manage which version of thedevice may function with specific versions of a device application usinga particular serial command. For example, a serial command may include atwo byte key code that can be issued by a value of code=00 when it sendsthe command to a device. An original version of a device can be designedwith a serial command function that will accept commands with a coderange of 00 to 0F, for example. In this manner, if another version ofthe device has an updated serial command that allows a code range, e.g.,of 00 to 1F, then the original device application can still work withthe original device, as well as any newer version of the deviceapplication that has codes in this range (e.g., specifically to aparticular serial command). If an updated devices application is notintended to be compatible with the original device version but only anew device version, then the code for the device application could beset between 10 to 1F. If the updated device is not intended to work withthe original device application, then the code for the device can be setto 10 to 1F.

In certain embodiments, the key code mechanism includes a key codecommunicated in a pairing message exchange between two devices in theanalyte monitoring system, in the same manner as described above fordevice serial commands accessed by a device application. In this case,the key code only needs to be included in a pairing message in order toenforce all communication restrictions between version of the device andthe analyte monitoring system, since they may not communicate (e.g.,except for pairing attempts) unless they are paired. This aspect canallow for full control over which device versions will work with theanalyte monitoring system.

By way of example, in some embodiments, a device could be designed toaccept serial commands with names $acona, $aconb, and $aconx, and thedevice application can issue $aconb. Moreover, the device could bedesigned to accept a serial command with three parameters and with fiveparameters.

In other embodiments, a configuration management mechanism is arrangedto mechanically key the sensor to only function with a particulartransmitter. For example, the sensor electrode contacts may be locatedin ways to allow some transmitters to properly connect and others tonot. Additionally, the sensor can be incorporated into a transmittermount that mechanically only fits the desired transmitter.

Certain embodiments allow interoperability of various sensor versionswith common transmitters and receivers but enforce compatibilityrequirements at the receiver or other device in the system by requiringthat a sensor code be entered prior to glucose calculation and display.The sensor code can be used to define a range of acceptable sensitivityof the device, and may be used to specify the sensitivity itself orcontribute to the glucose calculation. Moreover, the sensor may haveadditional elements that identify the sensor version. Likewise, thesensor code may be used exclusively to identify the sensor version. Thenthe receiver device can compare the entered sensor code to a list ofacceptable codes and if successful, allow glucose calculations ordisplay. Otherwise, the receiver can notify the user that the sensor isnot compatible. Furthermore, the receiver software can change algorithmsor other software function dependent upon the entered sensor code.

FIG. 4 is a flow diagram illustrating steps in an embodiment fordetermining the compatibility of a first device 402 in an analytemonitoring system 400. The first device 402 and the second device 404 inthe analyte monitoring system 400 can each include at least one of areceiver device, an analyte meter, a glucose monitor, an insulin pump, acontinuous analyte monitor, a cellular phone, a personal digitalassistant, a personal computer, a laptop computer, and/or a repeaterunit. In certain embodiments, a first device 402 sends data related toits configuration to the second device 404 (406). The request can besent, for example, wirelessly from the transmitter of the first device402 to the transceiver of the second device 404. The configuration offirst device 402, which can be an analyte sensor, can embody one or morevarious configurations that include different versions of the analytesensor. Each of the configurations of the first device 402 can includevarious specifications associated therewith, such as a specificcalibration factor and a software function that is used to processanalyte data that is obtained by the first device 402. The analyte datacan be processed using the software function at the first device 402 orone or more different devices.

Referring still to FIG. 4, the second device 404 receives the datarelated to the configuration of the first device 402 (408). The seconddevice 404 then retrieves data that is related to configurations thatare compatible with the analyte monitoring system 400 (410). The datarelated to the compatible configurations can be retrieved by the seconddevice 404, for example, from one or more of at least one storagecomponent of the second device 402, an internet based server, from acentral server, and/or a distributed server. Next, the second device 404compares the received data related to the configuration of the firstdevice 402 with the retrieved data that is related to one or moreconfigurations that are compatible with the analyte monitoring system400 (412). The second device 404 determines if the configuration of thefirst device 402 is compatible with the analyte monitoring system 400,based upon the comparison of the received data related to theconfiguration of the first device 402 with the retrieved data related toone or more configurations compatible with analyte monitoring system 400(414). The second device 404 annunciates or otherwise communicates analarm to alert a user if it is determined that the first device 402 isnot compatible with the analyte monitoring system 400 (416). The alarmmay be at least one of an audio alarm, a vibratory alarm, and a visualalarm operatively coupled to the second device 404. If however, thefirst device 402 is determined to be compatible with the analytemonitoring system 400, then the first device 402 may proceed to obtainanalyte data from the user.

FIG. 5 is a flow diagram illustrating steps in an embodiment fordetermining the compatibility of a first device 502 in an analytemonitoring system 500. The first device 502 and the second device 504 inthe analyte monitoring system 500 can each include at least one of areceiver device, an analyte meter, a glucose monitor, an insulin pump, acontinuous analyte monitor, a cellular phone, a personal digitalassistant, a personal computer, a laptop computer, and/or a repeaterunit. In certain embodiments, a first device 502 sends data related toits configuration to the second device 504 (506). The request can besent, for example, wirelessly from the transmitter of the first device502 to the transceiver of the second device 504. The configuration offirst device 502, which can be an analyte sensor, can embody one or morevarious configurations that include different versions of the analytesensor. Each of the configurations of the first device 502 can includevarious specifications associated therewith, such as a specificcalibration factor and a software function that is used to processanalyte data that is obtained by the first device 502. The analyte datacan be processed using the software function at the first device 502 orone or more different devices.

Referring still to FIG. 5, the second device 504 receives the datarelated to the configuration of the first device 502 (508). The seconddevice 504 then retrieves data that is related to the configurations thefirst device 502 may embody that are compatible with the analytemonitoring system 500 (510). The data related to the compatibleconfigurations can be retrieved by the second device 504, for example,from one or more of at least one storage component of the second device502, an internet based server, from a central server, and/or adistributed server. Next, the second device 504 compares the receiveddata related to the configuration of the first device 502 with theretrieved data that is related to one or more configurations that arecompatible with the analyte monitoring system 500 (512). The seconddevice 504 determines if the configuration of the first device 502 iscompatible with the analyte monitoring system 500, based upon thecomparison of the received data related to the configuration of thefirst device 502 with the retrieved data related to one or moreconfigurations compatible with analyte monitoring system 500 (514).Following the compatibility determination, the second device 504communicates, to the first device 502, data related to the compatibilitydetermination to the first device 502 (516). The data can becommunicated, for example, from a transmitter of the second device 504to a transceiver of the first device 502.

Still referring to FIG. 5, the first device 502 receives the datarelated to its compatibility with the analyte monitoring system 500 fromthe second device 504 (518) and alerts a user if it was determined bythe second device 504 that the first device 502 is not compatible withthe analyte monitoring system 500 (520), by annunciating or otherwisecommunicating an alarm. The alarm may be at least one of an audio alarm,a vibratory alarm, and a visual alarm. If the first device 502 isdetermined to be compatible with the analyte monitoring system 500, thenthe first device 502 may proceed to obtain analyte data from the user.

In another embodiment, the compatibility data can be transmitted to andsubsequently received by a third device (not shown), and the thirddevice can annunciate or otherwise communicate an alarm to alert theuser if the first device 502 is determined to not be compatible with theanalyte monitoring system 500.

FIG. 6 is a flow diagram illustrating steps in an embodiment fordetermining the compatibility of a first device 602 in an analytemonitoring system 600. The first device 602 and the second device 604 inthe analyte monitoring system 600 can each include at least one of areceiver device, an analyte meter, a glucose monitor, an insulin pump, acontinuous analyte monitor, a cellular phone, a personal digitalassistant, a personal computer, a laptop computer, and/or a repeaterunit. In certain embodiments, the first device 602 sends data related toits configuration to a second device 604 (606). The data can be sent,for example wirelessly from the transmitter of the first device 602 tothe transceiver of the second device 604. The configuration of firstdevice 602, which can be an analyte sensor, can embody one or morevarious configurations that include different versions of the analytesensor. Each of the configurations of the first device 602 can includevarious specifications associated therewith, such as a specificcalibration factor and a software function that is used to processanalyte data that is obtained by the first device 602. The analyte datacan be processed using the software function at the first device 602 orone or more different devices.

Referring still to FIG. 6, the second device 604 receives the datarelated to the configuration of the first device 602 (608). The seconddevice 604 then retrieves data that is related to one or more compatibleconfigurations of the first device 604 (610). In certain embodiments,the data includes software functions that correlate to the one or morecompatible configurations of the first device. The data can beretrieved, for example, from one or more storage components of thesecond device 602, an internet based server, from a central server,and/or a distributed server. Moreover, the data related to the one ormore compatible configurations of the first device 602, and the softwarefunctions correlated to the one or more compatible configurations can bestored at the same or separate locations, and can be retrieved at thesame time as the compatibility data or at a different time. The seconddevice 604 compares the received data with the retrieved data (612) anddetermines an appropriate software function that is correlated with theconfiguration of the first device 602 (614). The software function canbe used to process analyte data that is received from the first device602. The second device 604 receives analyte data that is obtained fromthe first device 602 (616), which can be sent, for example, wirelesslyfrom the transmitter of the first device 602 to the transceiver of thesecond device 604. The second device 604 then processes the receivedanalyte data using the determined appropriate software function (618)and displays the processed analyte data to a user (620).

In another embodiment, the second device 604 can communicate datarelated to the software function associated with the configuration ofthe first device 602 to a third device (not shown). The analyte data canbe communicated from the first device 602 to the third device, and thethird device can process the analyte data using the data related to thesoftware function received from the second device 604. The third devicemay also display the processed analyte data to the user.

In certain embodiments of the present disclosure, a computer-implementedmethod for determining a compatibility of one or more devices in ananalyte monitoring system includes receiving identification code datarelated to a configuration of a first device, retrieving informationincluding a predetermined list of one or more acceptable identificationcode data that is related to one or more first device configurationsthat are compatible with the analyte monitoring system, comparing thereceived identification code data with the one or more acceptableidentification codes from the retrieved predetermined list, anddetermining if the configuration of the first device is compatible withthe analyte monitoring system, based upon the received identificationcode data being identified in the predetermined list of acceptableidentification code data.

Certain aspects include alerting a user if it is determined that theconfiguration of the first device is not compatible with the analytemonitoring system.

Certain aspects include communicating data related to the determinationof the first device being compatible with the analyte monitoring systemof a second device.

Certain aspects include the first device communicating the data relatedto the compatibility of the first device to the second device using atleast one key code.

Certain aspects include the data related to the compatibility to thefirst device communicated using at least one of a radio-identificationcode or a resistive code or a combination thereof.

Certain aspects include the identification code data includinginformation related to a range of acceptable sensitivity of the firstdevice.

Certain aspects include the identification code data includinginformation related to a version of the first device.

Certain aspects include the user being alerted with at least one of anauditory alarm, a vibratory alarm, and a visual alarm.

Certain aspects include the first device being in fluid contact with aninterstitial fluid under a skin layer of a user.

Certain aspects include determining a suitable software function forprocessing analyte data obtained by the first device, based upon astored software function that corresponds to the received identificationcode data, wherein the software function is included in the informationrelated to a predetermined list of one or more acceptable identificationcode data.

Certain aspects include receiving analyte data obtained by the firstdevice that is related to an analyte level of a user, if it isdetermined that the first device is compatible with the analytemonitoring system, processing the received analyte data using thedetermined appropriate software function, and displaying the processedanalyte data to the user.

Certain aspects include the compatibility of the first device includinga key code of the first device being included in the predetermined list.

Certain aspects include the first device including at least one of acontinuous analyte monitor, an analyte sensor, a receiver device, arepeater device, or an insulin pump.

In certain embodiments of the present disclosure, a computer-implementedmethod for determining a compatibility of one or more devices in ananalyte monitoring system includes receiving identification code datarelated to a configuration of a first device, retrieving informationincluding a predetermined list of one or more identification codes thatare related to one or more first device configurations and one or moresoftware functions relating to the one or more first deviceconfigurations, comparing the received identification code data with theone or more identification codes, and determining an appropriatesoftware function for processing analyte data obtained by the firstdevice that is related to an analyte level of a user, based upon astored software function that corresponds to the received identificationcode data.

Certain aspects include the software function including an algorithm.

Certain aspects include the first device including at least one of acontinuous analyte monitor, an analyte sensor, a receiver device, arepeater device, or an insulin pump.

Certain aspects include the information including the predetermined listand the one or more software functions retrieved from at least one of astorage component, an online database, a central database, and adistributed database.

Certain aspects include the information including the predetermined listand the one or more software functions retrieved from differentlocations.

Various other modifications and alterations in the structure and methodof operation of the embodiments of the present disclosure will beapparent to those skilled in the art without departing from the scopeand spirit of the present disclosure. Although the present disclosurehas been described in connection with certain embodiments, it should beunderstood that the present disclosure as claimed should not be undulylimited to such embodiments. It is intended that the following claimsdefine the scope of the present disclosure and that structures andmethods within the scope of these claims and their equivalents becovered thereby.

1-18. (canceled)
 19. A system comprising: an integrated sensor andsensor electronics assembly comprising a glucose sensor, wherein theglucose sensor comprises a portion configured to be transcutaneouslypositioned in the body of a user and to sense glucose levels of theuser; and a drug delivery device comprising a wireless transmitterconfigured to transmit data related to a configuration of the drugdelivery device; a reader device comprising: a wireless receiver adaptedto receive: data related to a configuration of the integrated sensor andsensor electronics assembly; data indicative of an analyte level of auser from the integrated sensor and sensor electronics assembly; anddata related to the configuration of the drug delivery device; one ormore processors; and non-transitory memory comprising one or moresoftware functions stored thereon that, when executed by the one or moreprocessors, causes the one or more processors to: determine whether thedrug delivery device is compatible with the reader device based at leaston the data related to the configuration of the drug delivery device;determine whether the integrated sensor and sensor electronics assemblyis compatible with the reader device based at least on the data relatedto the configuration of the integrated sensor and sensor electronicsassembly; in response to a determination that the integrated sensor andsensor electronics assembly is compatible, process the data indicativeof the analyte level of the user received from the integrated sensor andsensor electronics assembly, and display the processed data indicativeof the analyte level of the user.
 20. The system of claim 19, whereinthe data related to the configuration of the integrated sensor andsensor electronics assembly comprises an identification code.
 21. Thesystem of claim 19, wherein the data related to the configuration of theintegrated sensor and sensor electronics assembly comprises a key code.22. The system of claim 19, wherein the one or more software functionsfurther cause the one or more processors to, in response to adetermination that the integrated sensor and sensor electronics assemblyis not compatible, communicate a first alarm to the user.
 23. The systemof claim 22, wherein the first alarm comprises at least one of an audioalarm, a vibratory alarm, and a visual alarm.
 24. The system of claim19, wherein the one or more software functions further cause the one ormore processors to, in response to a determination that the drugdelivery device is not compatible, communicate a second alarm to theuser.
 25. The system of claim 24, wherein the second alarm comprises atleast one of an audio alarm, a vibratory alarm, and a visual alarm. 26.The system of claim 19, wherein the drug delivery device furthercomprises a second wireless transceiver configured to receive dataindicative of the analyte level of the user from the integrated sensorand sensor electronics assembly.
 27. The system of claim 19, wherein thedrug delivery device is an insulin pump.
 28. The system of claim 19,wherein the one or more software functions further cause the one or moreprocessors to: determine whether the integrated sensor and sensorelectronics assembly is compatible with the reader device by comparing asensor version of the integrated sensor and sensor electronics assemblywith a predetermined list, and select a software function of the one ormore software functions based on the sensor version of the integratedsensor and sensor electronics assembly.
 29. The system of claim 19,wherein the drug delivery device further comprises: a second wirelessreceiver configured to receive data indicative of the analyte level ofthe user; a second one or more processors; a second non-transitorymemory comprising one or more software functions stored thereon that,when executed by the second one or more processors, causes the secondone or more processors to: display processed data indicative of theanalyte level of the user.
 30. A system comprising: an integrated sensorand sensor electronics assembly comprising a glucose sensor, wherein theglucose sensor comprises a portion configured to be transcutaneouslypositioned in the body of a user and to sense glucose levels of theuser; a reader device comprising: a first wireless receiver adapted toreceive: data related to a configuration of the integrated sensor andsensor electronics assembly; data indicative of an analyte level of auser from the integrated sensor and sensor electronics assembly; and oneor more processors; and non-transitory memory comprising one or moresoftware functions stored thereon that, when executed by the one or moreprocessors, causes the one or more processors to: retrieve a softwarefunction correlated with the configuration of the integrated sensor andsensor electronics assembly; process the data indicative of the analytelevel of the user received from the integrated sensor and sensorelectronics assembly using the software function; and display theprocessed data indicative of the analyte level of the user; a drugdelivery device comprising a second wireless receiver adapted to receivethe data indicative of an analyte level of a user.
 31. The system ofclaim 30, wherein the drug delivery device further comprises: a secondone or more processors; a second non-transitory memory comprising secondone or more software functions stored thereon that, when executed by thesecond one or more processors, causes the second one or more processorsto: display processed data indicative of the analyte level of the user.32. The system of claim 31, wherein the second one or more softwarefunctions further cause the second one or more processors to process thedata indicative of the analyte level of the user.
 33. The system ofclaim 32, wherein the second wireless receiver is adapted to receive thesoftware function correlated with the configuration of the integratedsensor and sensor electronics assembly from the reader device.
 34. Thesystem of claim 33, wherein the second one or more software functionsfurther cause the second one or more processors to process the dataindicative of the analyte level of the user using the software functioncorrelated with the configuration of the integrated sensor and sensorelectronics assembly from the reader device.
 35. The system of claim 30,wherein the drug delivery device is an insulin pump.
 36. The system ofclaim 30, wherein the software function is retrieved from a server. 37.The system of claim 30, wherein the software function is retrieved fromone or more components of the reader device.
 38. The system of claim 30,wherein the first wireless receiver is adapted to receive the dataindicative of an analyte level of a user from the integrated sensor andsensor electronics assembly via BLUETOOTH protocol.